Shriparna Roy and Prateek Jain
LONDON: A panel of advisers to the US health regulator on Tuesday voted against therapy based on the party drug MDMA for patients with post-traumatic stress disorder, dealing a major blow to an emerging field of therapy. psychedelic treatments,
The panel voted 10-1 against the therapy, saying its benefits do not outweigh its risks, while nine of the 11 members said available data did not demonstrate the drug’s effectiveness in patients. PTSD patients,
MDMA, commonly known as ecstasy or molly, has long been touted as a potential treatment. Mental health disordersDespite this, it is known for its illegal use.
This treatment is a capsule form of MDMA manufactured by a public benefit corporation Lycos Therapeuticswas to be administered by a licensed mental health provider in conjunction with talk therapy sessions.
Over 190 patients who took a dose of MDMA in addition to therapy experienced a significant reduction in PTSD scores compared to placebo.
FDA staff reviewers on Friday raised concerns about whether patients in the trials knew whether they were being given MDMA or a placebo, because it has psychedelic effects, which could obscure how well the drug works.
During the panel meeting, the FDA said there is a “severe deficiency” in the documentation of abuse-related adverse events, which can limit the agency’s ability to explain MDMA’s effects or determine abuse liability.
Scrutiny of the Lycos drug has intensified in recent months after the Institute for Clinical and Economic Review (ICER), an influential nonprofit, said there was “insufficient” evidence for the benefits of MDMA-based therapy.
In a letter dated Monday it was said that American Psychological Association He reiterated those comments, saying his panel of experts could not determine the balance between benefits and potential harms.
PTSD affects 13 million Americans and is especially common among war veterans. There is a great need for new treatments for this disorder because existing medications do not work on all patients.
FDA staff proposed restrictions on Lycos’ drug and a need for greater monitoring of its use in briefing documents on Friday. Staff also noted increased blood pressure and pulse and cases of liver toxicity in tests.
(Reporting by Sriparna Roy and Pratik Jain in Bengaluru; Editing by Shinjini Ganguly and Anil D’Silva)
us-fda-panel-votes-against-first-mdma-based-ptsd-treatment-et-healthworld-pharma
